BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIVA PULSE

    MDR report key: 14136072 · Received April 18, 2022

    Report

    Report Number
    3005099803-2022-01966
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 21, 2022
    Report Date
    October 20, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    UDI-DI
    08714729978626
    PMA / PMN Number
    K210925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, THIS PRODUCT WAS THOROUGHLY ANALYZED IN OUR QUALITY ASSURANCE LABORATORY. VISUAL ANALYSIS OF THE RETURNED FIBER CONFIRMED THE REPORTED SMOKE PRODUCED BY THE FIBER EVENT AS ANALYSIS IDENTIFIED A FRACTURE WITHIN THE CONNECTOR. DURING FUNCTIONAL TESTING, THERE WAS NO LIGHT PRESENT FROM THE SUB MINIATURE A (SMA) CONNECTOR, INDICATING A FRACTURE WITHIN THE CONNECTOR. THE FIBER CONNECTOR MAY HAVE A DEVELOPED A MICROFRACTURE THAT WITH USE OR HANDLING CAN BECOME LARGER RESULTING IN AN INSUFFICIENT AIMING BEAM AND LOW LASER ENERGY OUTPUT AND ULTIMATELY CAN LEAD THE CONNECTOR TO BECOME OVERHEATED. ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE. DO NOT BEND FIBER AT SHARP ANGLES. VISIBLE LIGHT SEEN LEAKING FROM THE FIBER INDICATES FIBER DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA PULSE LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE TO TREAT STONES IN THE KIDNEY AND URETER, PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS AN MOSES LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER CONNECTED TO THE LASER CONSOLE, A SMOKE WAS NOTICED AT THE CONNECTOR. UPON EXAMINATION, THE LASER FIBER WAS BROKEN ON THE BODY AND TIP. THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT AND THERE WERE NO FIBER FRAGMENTS FELL INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA PULSE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 21, 2022 THAT A FLEXIVA PULSE LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE TO TREAT STONES IN THE KIDNEY AND URETER, PERFORMED ON (B(6) 2022. THE LASER UNIT USED WAS AN MOSES LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER CONNECTED TO THE LASER CONSOLE, A SMOKE WAS NOTICED AT THE CONNECTOR. UPON EXAMINATION, THE LASER FIBER WAS BROKEN ON THE BODY AND TIP. THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT AND THERE WERE NO FIBER FRAGMENTS FELL INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA PULSE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657893 FLEXIVA PULSE POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION M006L8405911 0027419263 08714729978626

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown